RecruitingNCT07514962

Minimally Invasive Coronary Artery Bypass Supported by Cangrelor


Sponsor

Cardiocentro Ticino

Enrollment

30 participants

Start Date

May 12, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to find out whether it is safe and practical to perform MIDCAB surgery (a minimally invasive heart bypass procedure) while patients receive a continuous cangrelor infusion during the operation. Cangrelor is a medicine that helps prevent blood clots and works quickly through a vein drip. The study compares patients receiving cangrelor during surgery to patients who had the same surgery in the past while on aspirin, with or without cangrelor given beforehand. Study Question: Can MIDCAB surgery be safely performed under cangrelor infusion, without increasing the risk of bleeding or other complications? Hypothesis: Using cangrelor during MIDCAB surgery is safe and feasible, and it provides effective protection against blood clots during the procedure. This study will help doctors understand whether intraoperative cangrelor can improve patient safety and outcomes in minimally invasive heart surgery.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥18 years old
  • CABG with IMA-LAD graft in MIDCAB technique
  • Age ≥18 years old
  • CABG with IMA-LAD graft in MIDCAB technique
  • Signed informed consent

Exclusion Criteria14

  • Administration of fibrinolytics or GP IIb/IIIa inhibitors
  • Previous intracranial hemorrhage
  • Known bleeding diathesis
  • Patients undergoing concomitant PCI and MIDCAB
  • Severe renal or liver disease
  • Pregnancy or breast feeding
  • Unconsciousness
  • Known hypersensitivity to study drug (cangrelor)
  • Recent administration of fibrinolytics or GP IIb/IIIa inhibitors
  • Previous intracranial hemorrhage
  • Known bleeding diathesis
  • Patients undergoing concomitant PCI and MIDCAB
  • Severe renal or liver disease
  • Pregnancy or breast feeding

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Interventions

PROCEDURECangrelor-guided MIDCAB surgery (for the prospective cases)

Cangrelor-guided MIDCAB surgery: Patients undergo minimally invasive direct coronary artery bypass (MIDCAB) with continuous intravenous cangrelor infusion at 0.75 μg/kg per minute. Prior oral antiplatelet therapy is discontinued, and platelet function is monitored daily using Multiplate® testing. Cangrelor infusion is started when platelet aggregation reaches predefined thresholds and continued throughout surgery until it is safe to restart oral antiplatelet therapy.

PROCEDUREAspirin MIDCAB surgery (for the historical controls)

Aspirin MIDCAB surgery: Historical control patients underwent MIDCAB under aspirin therapy, with or without prior bridging with cangrelor. Perioperative management follows standard care, including anticoagulation with unfractionated heparin during surgery and routine monitoring of laboratory and clinical outcomes.


Locations(1)

Istituto Cardiocentro Ticino

Lugano, Ch/ti, Switzerland

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NCT07514962


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